CurrentMass General Brigham Health PlanPolicy N/A

Disposable Insulin Delivery Systems (OmniPod family and V-Go) — Coverage Criteria

Policy governing prior authorization, quantity limits, and coverage criteria for disposable insulin delivery systems (OmniPod family and V-Go) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyDisposable Insulin Delivery Systems (OmniPod family and V-Go) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTitle updatereauthorization documentation clarified

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prescriber attestation that the member has a positive clinical response to therapy for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Policy title updated to include OmniPod 5 and OmniPod Go.

Reauthorization criteria updated to require prescriber attestation that the member has a positive clinical response to therapy.

12 monthsApproval duration

10/30dOmniPod refill limit

1/5yOmniPod starter kit

30/30dV-Go quantity limit

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Initial authorization criteria

Authorization may be granted when EITHER of the following is true:

Entry condition — current use for new-plan members: Member is new to the plan within the past 90 days and is currently receiving the requested disposable insulin delivery system (excluding products obtained as samples or via the manufacturer's patient assistance programs).

Source: coverage guidelines

Alternative — meet all listed clinical criteria: Member meets ALL of the following grouped clinical criteria:

See nested clinical criteria

Nested clinical criteria

Injection history: Member is managing diabetes with multiple daily insulin injections (at least 3 injections per day) with frequent self-adjustments of the insulin dose for at least 6 months.>=3 injections/day for >=6 months
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Self-monitoring: Documented frequency of glucose self-testing averaging at least 4 times per day for the past two months.>=4 times/day for 2 months
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Additional requirement (one of): Member meets ONE of the following: has been using a continuous glucose monitor (CGM) for the past two months; has completed a comprehensive diabetes education program; elevated HbA1c (>7%); wide pre-meal blood glucose fluctuations; history of recurrent hypoglycemia (blood glucose <70 mg/dL); 'Dawn' phenomenon with fasting blood sugars frequently >200 mg/dL; history of severe glycemic excursions.
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Continuation / Reauthorization

Reauthorization (Continuation) criteria — requests for reauthorization will be approved when ALL of the following are met:

Reauthorization requirement: Prescriber attestation that the member has a positive clinical response to therapy.

Required documentation for reauthorization

For members who are new to the plan within the past 90 days, the policy permits expedited authorization when the member is already receiving the requested disposable insulin delivery system. However, items obtained as samples or provided through a manufacturer's patient assistance program are explicitly excluded from qualifying the member under this "currently receiving device" pathway.

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for disposable insulin delivery systems. Prior authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested device (excluding samples or manufacturer patient assistance program supplies).

Members new to the plan within 90 days who are currently using the requested device (excluding samples or patient assistance program supplies)

Step Therapy

Step Therapy Note

Program notes Step Therapy as the program type but no additional step requirements beyond the clinical criteria are specified in the policy. Providers should follow the clinical eligibility criteria; there are no listed prerequisite trials of other devices or therapies required prior to authorization.

Documentation Required

Documentation Required for Reauthorization

Requests for reauthorization require prescriber attestation that the member has had a positive clinical response to therapy.

Prescriber attestation of positive clinical response required for reauthorization

Denial Risk

Denial Triggers

Authorization may be denied if the member is not new to the plan within the past 90 days and does not meet all listed clinical criteria (for example: not managing diabetes with ≥3 daily injections for ≥6 months, insufficient self-monitoring frequency, lack of prior diabetes education, absence of CGM use where specified, or no evidence of recurrent hypoglycemia, wide glucose fluctuations, elevated A1c, dawn phenomenon, or severe glycemic excursions).

Denial risk when member is not new to plan within 90 days and clinical criteria not met
Clinical triggers include insufficient injection history, inadequate glucose self-testing (average <4 times/day over prior 2 months), lack of diabetes education, or absence of documented glycemic issues noted in criteria

Background

Disposable insulin delivery systems such as OmniPod variants and V-Go provide continuous subcutaneous insulin infusion as an alternative to multiple daily injections for patients with insulin-requiring diabetes. The policy’s coverage pathway for members new to the plan allows authorization when the member is already receiving the requested device, subject to the exclusion that devices obtained as samples or through a manufacturer patient assistance program do not qualify under that pathway.